Phase 1
Completed N=98
Comparison Bioequivalence Study: Pre-filled Syringe (Reference) Versus Auto-injection Device (Test)
Healthy
Source: ClinicalTrials.gov NCT00845663 ↗
Enrolled (actual)
98
Serious AEs
2.0%
Results posted
Nov 2009
Primary outcomePrimary: Area Under the Plasma Drug Concentration-time Curve From Time 0 to Infinity (AUC) — 1308; 1326 microgram *day/mL
Summary
To compare the bioavailability of a single 400 mg dose of certolizumab pegol solution (2 x 200mg subcutaneous injections) injected either by a pre-filled syringe (reference) or by an auto-injection device (test).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Plasma Drug Concentration-time Curve From Time 0 to Infinity (AUC) |
1308; 1326 | — |
| PRIMARY Area Under the Plasma Drug Concentration-time Curve From Time 0 to the Last Quantifiable Point (AUC(0-t)) |
1269; 1240 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) |
61.6; 60.1 | — |
| SECONDARY Time Point Where Log-linear Elimination Phase Begins (TLIN) |
21.0; 21.0 | — |
| SECONDARY Lowest Quantifiable Concentration Time (LQCT) |
56.0; 84.0 | — |
| SECONDARY Apparent Terminal Elimination Rate Constant (λz) |
0.0732; 0.0639 | — |
| SECONDARY Apparent Terminal Elimination Half-life (t1/2) |
10.9; 11.7 | — |
| SECONDARY Time Corresponding to Cmax (Tmax) |
5.00; 5.00 | — |
| SECONDARY Apparent Total Body Clearance (CL/F) |
306; 302 | — |
| SECONDARY Apparent Volume of Distribution (Vz/F) |
4.58; 4.92 | — |
| SECONDARY Number of Subjects With Anti-certolizumab Pegol Antibody Plasma Level >2.4 Units/mL |
22; 15 | — |
| SECONDARY Injection Pain Assessment on a Visual Analog Scale (VAS) Per Formulation and Per Time Point as Well as Change From Baseline (=Immediately After Injection) at One Hour After Injection |
28.9; 20.9; 2.3; 1.1; -26.6; -19.8 | — |
| SECONDARY Injection Questionnaire Per Formulation and Per Time Point - Afraid of Needles |
13; 18; 17; 16; 17; 14 | — |
| SECONDARY Injection Questionnaire Per Formulation and Per Time Point - Afraid of Having Injections |
11; 13; 21; 17; 16; 19 | — |
| SECONDARY Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain |
11; 7; 16; 26; 18; 13 | — |
| SECONDARY Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation |
23; 23; 12; 13; 6; 11 | — |
| SECONDARY Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation |
42; 37; 6; 11; 1; 1 | — |
| SECONDARY Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching |
46; 44; 3; 5; 0; 0 | — |
| SECONDARY Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness |
24; 39; 19; 8; 6; 2 | — |
| SECONDARY Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling |
37; 34; 11; 14; 1; 1 | — |
| SECONDARY Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising |
46; 47; 3; 2; 0; 0 | — |
| SECONDARY Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening |
37; 34; 11; 12; 1; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Age: 18-55 years.
- A Body mass Index (BMI) of 18 to 28 kg/m
- Good physical and mental health status determined on the basis of the medical history and a general clinical examination
- Electrocardiogram and clinical laboratory tests interpreted as "normal"
- QuantiFERON-TB test negative
- female subjects: medically accepted method of contraception
Exclusion Criteria
- prohibited concomitant medication
- administered vaccines and immunoglobulins in the month preceding the certolizumab pegol injection
- history of significant disease, allergies
- history of drug and/or alcohol abuse
- hepatic enzyme inducing drug within 2 months before study drug administration
- any drugs having influence of the immune response and antibiotic in the month preceding the inclusion
- known to be intolerant to PEG
- previously received certolizumab pegol
- previously received an antibody product within 5-half lives of the antibody or within 3 months of the start of the study
- history of tuberculosis
- have serum hepatitis or is carrier of the Hepatitis B surface antigen (HBs Ag), or Hepatitis C antibody or who is HIV positive
Data sourced from ClinicalTrials.gov (NCT00845663). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.